Safety syringe and safety dose combination kit

ABSTRACT

A syringe calibrated for use with a single predetermined medication including a barrel having an internal reservoir volumetrically calibrated to contain the medication, a plunger received within the barrel, a first set of graduated indicia marked on the barrel indicating a first predetermined patient characteristic expressed in one of kg, max kg, lb, max lb, m 2 , and max m 2 , a second set of graduated indicia marked on the barrel indicating a second predetermined patient characteristic, different from the first predetermined patient characteristic, and expressed in one of kg, max kg, lb, max lb, m 2 , and max m 2 , and graduation lines marked on the barrel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Continuation application claims priority from U.S. patentapplication Ser. No. 13/748,859 filed Jan. 24, 2013, which claimspriority from U.S. Patent App. No. 61/591,683 filed Jan. 27, 2012, theentirety of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention is related, generally, to the field of medicinedelivery apparatuses, systems and methods. More specifically,embodiments of the present invention are related to articles, systems,and methods that are used in the administration of medications topatients, particularly via syringe.

BACKGROUND

Medical Administered Errors (“MAE”) are occurring in the field of healthcare at an epidemic proportion, with statistical figures that arestaggering. For instance, more people die in a given year as a result ofmedical errors than from motor vehicle accidents (43,458), breast cancer(42,297), or AIDS (16,516).¹ (1) Centers for Disease Control andPrevention (National Center for Health Statistics) Births and Deaths:Preliminary Data for 1998. National Vital Statistics Reports. 47(25):6,1999.

The United States Food and Drug Administration (“FDA”) evaluated reportsof fatal medication errors that it received from 1993 to 1998 and foundthat the most common types of errors occurred as the result of theinjection of medication. These errors included: the administration of animproper dose (41 percent); the administration of the wrong medication(16 percent); and the use of the wrong route of administration (16percent). The FDA also notes in a study that medication errors injureapproximately 1.3 million people annually in the US alone. Children areconsidered the most vulnerable population because their smaller bodymasses make them more sensitive to overdoses or underdoses ofmedication, which could result in the ineffective treatment of theunderlying condition, adverse reaction, illness, and even death.

In other reports it has been noted that medication errors occur inapproximately one out of every five doses given in hospitals. These andother medication errors reported to the FDA stem from poorcommunication; misinterpreted handwriting; drug name confusion; drugstrength, inaccurate dosage calculation, confusing drug labeling andpackaging; lack of employee knowledge; and lack of patient understandingabout a drug's directions.

In 2006, The National Committee of Science conducted a study entitledPreventing Medication Errors. The Committee estimated that, on average,a hospital patient is subject to at least one medication error per day,with considerable variation in error rates across facilities. Estimatesof incidences of preventable ADE range from 380,000 to 450,000 annuallyin acute care hospitals alone.

The Institute of Medicine (TOM) released a report in November 1999,entitled “To Err is Human: Building a Safer Health System.” According tothe report, between 44,000 and 98,000 deaths may result each year frommedical errors in US hospitals alone.

The resulting financial impact to the healthcare industry in the UnitedStates, according to the American Academy of Pediatrics (“AAP”), isestimated to exceed $100 billion annually. In addition, the AAP reportsthat “incorrect dosing is the most commonly reported error, includingcomputation and dosage intervals”.

Clearly studies consistently show the consolidation and preparation ofthe correct components and the subsequent correlation and calculation ofan injectable medication for a particular patient are the direct causeof the leading MAEs and continues to be a extremely procedurallychallenging issue for the health care industry. These errors areexacerbated based in large part by confusion of medications with similarnames and labels, different dosages of the same medications, medicationswith same name yet measured in different unit strengths, calculation ofdosage to patients weight or more complex calculations, such as, forexample, dosage to body surface area, pediatrics and renal impairedreduced dosage calculated from adult weight dose, different diluents fordifferent routes of administration even for the same medication,multiple diluents, various dilution steps, measurements and calculationsfor a single medication, all intermixed with a fast pace, high stressenvironment, coupled with extended working hours, and emergencyprocedures to name a few. These variables and elements, combined withinthis environment, will continue to accelerate user errors and exacerbatethe already confusing process associated with correctly preparing anadministering an injectable medication.

SUMMARY OF THE INVENTION

An invention that prevents these persistent errors from occurring duringthese vital procedures or that completely eliminates the procedures byreplacing them with passive safety systems and devices to accomplish thesame by the same administration of the medication by the same acceptableindustry standards, would save countless lives.

It is the purpose of this invention to substantially eliminate theseleading causes of MAE by substantially completely eliminating thecurrent procedures that users must follow in order to consolidate andcorrelate the correct components of apparatuses for the administrationof medication to patients and to substantially eliminate the need forusers to perform calculations and/or measurements to determine theamount of diluent(s) for the medication and all procedures for anycalculation of the dosage of the medication to a specific patient weightor body surface area.

Embodiments of the present invention are directed to new and improvedapparatuses, kits, designs and methods for administering medicationthrough pharmaceutical syringes, or other apparatuses designed toincrease efficiency, substantially eliminate multiple procedural usersteps, improve patient-specific precise dosing and to substantiallyprevent or eliminate MAE, while significantly reducing the overall costsassociated with the administration of medicine.

In one embodiment, the present invention is directed to a method forextracting a medication comprising the steps of providing a medicationin a medication container, providing a first syringe, with the firstsyringe comprising an indicia relating to a recommended dosage of themedication. The container may be a vial, an ampoule, or any suitablemedicinal container. The need for calculations or correlations of amedication dosage to a patient's weight or body surface area areobviated, as a portion of the first syringe is presented to or deliveredinto the container, and the first syringe is filled to a recommendeddosage with the injectable medication, and once again obviating the needfor calculations or correlations of a medication dosage to a patient'sweight or body surface area. The injectable medication is thenadministered into a patient. Preferably, the dosage is indicated on thesyringe in volumetric dosage, and preferably, the dosage is indicated inunits such as, for example, CC, IU, MG, MCG, and ML to patient weight orbody surface area. Preferably, the patient weight or body surface areais indicated in units including, for example, KG, LB, G and m².

In a further embodiment, the present invention further comprises thesteps of providing a lyophilized or dry-filled composition in themedication container, providing a diluent in a diluent container, andreconstituting the lyophilized or dry filled composition by providingthe diluent to the lyophilized or dry-filled composition.

In a still further embodiment, a preferred method further comprises thesteps of providing a diluent container to reconstitute the medication,and wherein the first syringe is volumetrically calibrated withmeasurement indicia and recommended dosage, providing a second syringe,said second syringe volumetrically calibrated with measurement indiciafor the diluent, extracting a correct amount of diluent from the diluentcontainer using the second syringe, injecting the extracted diluent fromthe second syringe into the medication container, reconstituting themedication; and obviating the need for calculating or correlating themedication, or the syringe to a patient's weight or body surface area.

According to the present disclosure, a syringe is disclosed comprising abarrel comprising at least two substantially permanent calibratedmeasurement indicia, wherein a first indicia comprises a volumetricdosage of a medication that correlates a recommended dosage to a secondpermanent measurement indicia for a patient's weight or patient's BSA.The recommended dosage is a manufacturer's recommended dosage of themedication, and preferably, the barrel of the syringe comprises a thirdor multiple substantially permanent calibrated measurement indiciacorrelated to a manufacturer's maximum dosage to a patient's weight orpatient's BSA. According to further embodiments, the barrel comprises asubstantially permanent calibrated measurement indicia correlating to aspecific dosage schedule of a specific medication to patient weight. Thepresent disclosure further contemplates that desired printed informationidentifying a medication on a syringe component can exist on one of moreof any syringe component including a barrel, a plunger nested within abarrel, and combinations thereof. The information includes: medicationname, medication strength, medication dosage-to-weight, and combinationsthereof. The printed information is preferably the name of medication,the strength of medication, medication dosage-to-weight, andcombinations thereof.

The syringe may be pre-filled with a medication, with the syringecomprising a substantially permanently calibrated measurement indiciacorrelating the dosage of the medication to a patient's weight. Theplunger is preferably dimensioned to nest within the barrel, and plungermay be permanently calibrated with measurement indicia correlating thedosage of the medication to the patient weight.

The present disclosure is also directed to a kit comprising apre-measured volumetrically scaled medication container having apreselected volume and a syringe having a volume capacity substantiallyequivalent to the preselected volume and a barrel comprising at leasttwo substantially permanent calibrated measurement indicia, wherein afirst indicia is a recommended dosage that specifically correlates therecommended dosage to a second substantially permanent measurementindicia for a patient's weight. The kit is preferably pre-packaged andtamper-resistant. The container is selected from the group including avial, an ampoule, and combinations thereof. The syringe is filled with avolume from the medication container to a maximum calibrated measurementindicia without any calculations or correlations. The measurementindicia are calibrated to deliver the correct doses of the recommendeddosage of a specific medication to a particular patient weight withoutany calculations or correlations.

In addition, the present disclosure is directed to a kit comprising amedication in a medication container and a first syringe correspondingto the medication container, with the medication volume scaled in themedication container to correlate with the first syringe, and thesyringe comprising an indicia calibrated to deliver the medicationaccording to a recommended medication dosage to a patient weight or bodysurface area.

In addition, the present disclosure is directed to a method fordelivering medication to a patient via a syringe comprising the steps ofproviding a medication in a container providing a syringe comprisingcalibrated measurement indicia and a recommended or maximum dosage ofthe medication without the need for any calculations or correlations ofthe medication dosage to the patient's specific weight, correlating thevolume of the medication in the container to specifically correlate themedication to calibrated measurement indicia of the syringe, deliveringa portion of the syringe into the container and filling the syringe to arecommended dosage of the medication without the need for anycalculations or correlations of the medication dosage to the patient'sspecific weight and administering the medication into a patient. Thesyringe preferably is filled to a recommended or maximum dosage of themedication such that the indicia would correctly administer arecommended dosage-to-weight volume without additional calculations.Preferably the volume of the syringe is correlated through reducing theinterior diameter of the barrel core to provide an enlarged indicia onthe syringe for a reduced patient weight range and for bettervisibility, accuracy, and lower incremental doses for smaller volumesinjections.

Still further, the present disclosure relates to a method for extractinga medication from a container comprising the steps of providing amedication in a container, providing a syringe comprising a calibrationrelating to the medication and featuring a first volumetric indicia fordosage strength and a second indicia relating to a recommended patientweight or body surface area (BSA). The calibration does not require anyfurther calculations or correlations of the medication dosage to thepatient's specific weight. A portion of the syringe is delivered intothe container and the syringe is filled to a recommended dosage with theinjectable medication without the need for any calculations ofcorrelations of the medication dosage to the patient's specific weight.The injectable medication is then administered to the patient via thesyringe.

In one embodiment, the present invention substantially eliminates asmany sources of human error as possible in the administration ofinjectable medications by eliminating the user's need to performseparate calculations and correlations without deviating from industryacceptable practices or the instructions for administration issued bythe manufacturer of the medication.

More particularly, embodiments of the present invention completelyremove and eliminate the practices and procedures currently used in thehealthcare industry that are responsible for the primary causes ofMedical Administered Errors by injectable administration. Specifically,embodiments of the present invention eliminate the procedures, methods,research and verification ordinarily conducted by users through theconsolidation of, for example, the correct medication for patient class,the correct diluent(s), syringe(s) and needle(s) for the medication,correlation of the correct diluent(s), syringe and needle for the routeof administration of the particular medication, calculation of correctamount of diluent for the medication, as well all calculations necessaryto administer the correct drug dosage to the specific patient, etc.

In a preferred embodiment of the present invention, a syringe isdesigned and volumetrically calibrated for use with a specificmedication within a combinatorial tamper-resistant kit, whereby thesyringe is used to load and administer the dosage that the manufacturerrecommends for the patient's particular body weight, or body surfacearea (BSA), solely through its design. The syringe does this withoutrequiring the user to perform any calculations, make any correlations oruse any other components and/or devices. The syringe's volumetricallycalibrated substantially permanent indicia indicate the amount ofmedication to be administered to a patient of a given weight or morecomplex patient feature and measurement, such as, for example, bodysurface area (BSA) measured in m², for ultra-sensitive, precise dosageused in biologics and oncology medications, among others. No additionalsteps or devices are necessary.

More particularly, embodiments of the present invention are directed toa process for extracting an injectable medication by providing acomposition to be injected and a syringe comprising recommended and/ormaximum dosage-to-weight indicia of the injectable medication. Thesyringe is filled with injectable medication from the container (vial,ampoule, etc.) to a recommended or maximum dosage (based on the bodyweight of the patient) of the injectable medication without the need forany calculations or correlations of the medication's dosage schedule tothe patient's specific weight and administered into the patient.

Further embodiments of the present invention are directed to apre-packaged, tamper-resistant kit comprising a pre-measured,volumetrically calibrated, scaled container that specifically correlatesthe medication dosage strength and/or volume to the indicia on thesyringe within the kit. The syringe comprises a barrel bearing at leasttwo permanent calibrated measurement indicia, wherein the first indiciais a recommended dosage that specifically correlates the recommendeddosage to a second permanent measurement indicia for a patient's weight.The medication may be scaled to individual patient range within the kitcorrelating to the calibrated syringe indicia for that targeted patientrange, provides a precise lower dose calibration scale, reduces thepotential severity of an overdose, and also provides for apatient-specific injection range that significantly reduces wastemedication left within the container associated by typical industrystandard practices.

Still further embodiments of the present invention are directed to amethod for delivering medication to a patient via a syringe by providinga combination kit comprising a medication in a container, and providinga syringe, said syringe comprising calibrated measurement indicia and arecommended or maximum dosage of the medication without the need for anycalculations or correlations of the medication dosage to the patient'sspecific weight or BSA. The volume of the medication is calculated inthe container to specifically correlate the medication to calibratedmeasurement indicia of a syringe. A portion of the syringe is directedinto the container and filled to a recommended dosage of the medicationwithout the need for any calculations or correlations of the medicationdosage to the patient's specific weight, and the medication isadministered into the patient.

A further embodiment of the present invention is directed to a methodfor delivering medication to a patient via a syringe by providing amedication in a container and providing a syringe that bears calibratedmeasurement indicia for that particular medication that is thencalibrated and correlated to another indicia measurement for arecommended and/or maximum dosage to patient weight or BSA of themedication without the need for the user to perform any calculations orcorrelations of the medication dosage to the patient's specific weight.This enables the user to insert a portion of the syringe into thecontainer and fill the syringe to a recommended or maximum dosage of themedication based upon the patient's body weight such that the indiciawould allow the syringe to be correctly loaded with the recommendeddosage-to-weight volume for the medication without additionalcalculations.

In yet a further embodiment of the present invention, the syringe barrelmay be manufactured to have a specific core diameter or other volumetriccalibration adjustment to provide enlarged elongated targeted indicia onthe syringe for specific patient weight or BSA range, thus providingbetter visibility, accuracy, and lower incremental calibration doses forsmaller volumes injections, such as for neonatals and pediatrics.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying Figures illustrate aspects of embodiments of thepresent invention. These, together with the description illustrate theobjects, advantages and principles of embodiments of the presentinvention. In the Figures:

FIGS. 1, 2 and 3 illustrate close-up views of the syringe's indicia andsafety re-verification indicators including indicia and indicators thatappear on the syringe;

FIG. 4 is a close-up view of the plunger section of a syringe accordingto one embodiment of the present invention with permanent identifyingdestination of the medication for which it is designed and intended for,medication dosage to weight and that the syringe is not to utilizedoutside of the kit or with any other medication;

FIG. 5 illustrates the syringes according to embodiments of the presentinvention with various indicia and the plunger designations, includingthe name of the medication, dosage of the medication to the weight ofthe patient, and that the syringe is exclusively calibrated to thatmedication;

FIG. 6 illustrates an industry standard pre-filled 500 mg vial and 100mg ampoule that would be used for the injection of 8 kg or less into apediatric patient and the unused medication that would be wasted if a 5mg/kg dosage were to be administered;

FIG. 6A illustrates a volumetrically-scaled patient weight rangespecific pre-filled 40 mg vial or ampoule within the combination kitthat would be utilized for the injection of less than 8 kg of medicationto a pediatric patient that would result in little or no waste,depending on the patient injection;

FIG. 6B illustrates a view of the syringe contained within a combinationkit of calibrated for a medication strength of 5 mg/kg for pediatricrange weights of 0.5 to 8.0 kg;

FIG. 7 illustrates views of a two syringe multi-diluent vial combinationkit, where by one syringe can be calibrated and its indicia correlatedspecifically to the diluent(s) and the withdrawal and introduction ofthem into the medication for reconstitution. The other syringe iscalibrated and its indicia correlated specifically for the medicationand the withdrawal and administration of the dosage of the medication toindividual patient weight or BSA;

FIG. 8 illustrates a cross section of the syringe showing the exteriordiameter of the barrel in various options available yet the inner barrelcalibrated to individual dosage volumes; and

FIGS. 9-10 illustrate a typical small volume injection within a industrystandard 3 ml volume syringe and the indicated level of the dosage onthe indicia. FIG. 10 illustrates a syringe according to embodiments ofthe present invention; the syringe having the same outer diameter as the3 ml volume syringe of FIG. 9, yet through it calibrated inner barreloffering enhanced visibility as it extends a 1 ml volume through thefull indicia of the syringe in lower incremental doses for increasedprecision.

DETAILED DESCRIPTION

According to one embodiment of the present invention, a syringe or otherapparatus for medicinal administration (hereinafter referred to as a“syringe”) may be designed for use with a specific medication. Thesyringe is preferably clearly and conspicuously labeled to indicate thename of the medication it is intended to administer. In one preferredembodiment, the syringe bears a calibration scale on one or more of itsbarrel, its plunger, or other component that is marked in indicia of apatient characteristic, such as, for example, patient weight or bodysurface area (BSA, measured as m²). This enables the user to administera manufacturer's recommended dosage of a subject medication, forexample, strictly according to a patient's weight, or other desiredcharacteristic, without performing any mathematical calculations,computations or correlations, etc. (See FIG. 5, feature 400).

The syringe's indicia may also provide a maximum calibrated column thatcorrelates to the maximum MCG, CC, IU, MG, ML dosage-to-patient'sparticular weight or BSA, (G, KG, LB, m²) utilizing the recommendedmanufacturer's dosage schedule. FIGS. 1-3 illustrate several variationsof indicia 100 for embodiments of the present invention. Indicia 100comprises measuring characteristics 101 and graduation markings 102 thatcorrelate and correspond the patient's weight or BSA measures in KG 103,or m² 104, or LB or G to the recommended dosage for the patient's weightcomprising measuring characteristics MG 107, IU 108 mL 109 or MCG.Indicia 100 may also include measuring characteristics 101 andgraduation markings 102 that correlate and correspond to the recommendedmaximum dosage based on the patient's weight 105 or BSA 106. Indicia 100may also include measuring characters 101 and graduation markings 102that correspond to the strength (or concentration) 107 of the medicationwithin the dosage. Indicia 100 may also include measuring characters 101and graduation markings 102 that correspond to the amount of a substance108 based on the biological activity or effect of the medication withinthe dosage. Indicia 100 may also comprise measuring characters 101 andgraduation markings 102 that correspond to volume 109 of the medication.

According to the present disclosure, FIG. 4 shows a pre-calibratedsyringe 400 comprising a plunger 401, a syringe barrel 402, and a needle403. The syringe barrel 402 comprises measuring indicia 100corresponding to dosages based on a patient's weight 103 or body surfacearea (not shown). The syringe preferably comprises a gasket 404 locatedat and attached to one end of plunger 401. Gasket 404 is preferably madefrom rubber or other sterilizable material and may be modified as to becolored or exhibit fluorescent properties in natural light or uponexposure to light outside of the visible spectrum (e.g. ultravioletlight, infrared, etc.) to assist in the visible accuracy obtained inpreparing and verifying the dosage per calibration scale.

FIG. 5 shows examples of pre-calibrated syringes 400. The syringe 400comprises a plunger 401 and a syringe barrel 402 comprising measuringindicia 100 that correlate and correspond medication dosage in MG 107,IU 108, mL 109 or MCG to an individual patient's weight 103 or bodysurface area (not shown). According to one embodiment, the plunger 401preferably comprises a clear and conspicuous substantially permanentindication 405 of at least the medication name 406, dosage strength,recommended dosage to weight 408, or weight range 409 or the medicationcontained in the syringe. The syringe provides users with several keyvisual aids that help to avoid, for example, administration errors inthe dosage of the medication, the use of the medication itself, thestrength of the medication, etc.

FIG. 6 shows an industry standard pre-filled (either dry or liquid) 500mg vial 600 and 100 mg ampoule 601 of injectable medication. In thisexample, a low dose pediatric or reduced-weight patient dosage injectionof 5 mg per kg for an 8 kg patient would require 40 mg 603 and 608. Bycontrast, FIG. 6A illustrates a volumetrically-scaled patient weightrange pre-filled 40 mg 606 in vial 604 or ampoule 605 within thecombination kit that would be used for the injection of the medicationto, for example, the 8 kg or less pediatric patient that would result ina minimum 460 mg of the 500 mg vial not being wasted (the volume shownas 602) or in a minimum of 60 mg of the 100 mg ampoule not being wasted(the volume shown as 607) as would otherwise occur. (See FIG. 6).

FIG. 6B shows a volumetrically calibrated syringe 400 to specificallycorrelate to the medication with the kit, and volume-scaled small dosepatient range 606 to solely correlate with the vial or ampoulemedication dosage strength of 5 mg/kg for pediatric range weights offrom about 0.5 to about 8.0 kg.

FIG. 7 illustrates variations of a pre-packed kit 700 contemplated byembodiments of the present invention. The pre-packaged kits 700 consistof a single unit, preferably tamper-resistant container packaged as a“blister pack” or as a “clamshell”, as would be readily understood inthe packaging field. Such packaging 701 is preferably made fromsterilizable materials including a plastic such as, for example, highdensity polyethylene (HDPE), polyethylene terephthalate (PET),polycarbonate, etc. The kit comprises pre-filled (dry or liquid)medication vials 604, or ampoules 605, corresponding diluent(s) (ifapplicable) 702, hypodermic needles 403, and the pre-calibrated syringes400 for the medication contained by the kit.

FIG. 8 illustrates a pre-calibrated syringe barrel 402 according toembodiments of the present invention. The syringe barrel comprisesmeasuring indicia 100 that correspond to dosages based on a patient'sweight 103 or BSA (not shown). Measuring indicia 100 may appear on theinner surface and/or outer surface of the barrel 401, or the barrel maybe manufactured to position the indicia at a pre-selected distancelocated between the inner and outer surface of the barrel 402, or anycombination thereof as desired. The syringe barrel 402 comprises aninternal core diameter 801 and an outer diameter 800, both of which maybe adjusted through desired and pre-selected design features andmanufacturing. However, the outer diameter 800 may be dimensioned to beconsistent with industry standard dimension, thus enabling the syringeuser to have the dexterity of an accepted, larger diameter barrelsyringe (such as, for the preparation and administration of medication),as well as better visibility, particularly for smaller volumeinjections, and visibility of the corresponding indicia.

FIG. 9 illustrates an industry standard 3 ml syringe 900. The syringe900 comprises a plunger 901, a syringe barrel 902, and a needle 903, orsharp. Measuring indicia 904 may appear on the inner surface, outersurface of the barrel 902, or the barrel may be manufactured to positionthe indicia at a pre-selected distance located between the inner andouter surface of the barrel 902, or on any combination of surfacesthereof. The measuring indicia preferably correspond to the volume 905of the syringe. Plunger 901 comprises a gasket 906 at one end of plunger901. The gasket 906 is preferably a rubber piston gasket that indicatesthe volume within the syringe barrel 902. The internal diameter 907 andthe outer diameter 908 of the syringe barrel 902 may be manufactured toindustry standard sizes.

FIG. 10 shows a pre-calibrated syringe 400 according to embodiments ofthe present invention. Syringe 400 comprises a plunger 401, a syringebarrel 402 and a needle 403. Syringe barrel 402 comprises measuringindicia 100 that may appear on the inner surface, outer surface of thebarrel 402, or the barrel may be manufactured to position the indicia ata pre-selected distance located between the inner and outer surface ofthe barrel 402, or on any combination of surfaces thereof. Plunger 401comprises a gasket 404 at one end of plunger 401. The gasket 404 ispreferably a rubber piston gasket that indicates the volume within thesyringe barrel 402. The internal, or core diameter 801 and the outerdiameter 800 of the syringe barrel 402, both may be adjusted thoughdesired and pre-selected design features and manufacturing. However, theouter diameter 800 may be dimensioned to be consistent with industrystandard dimension, thus enabling the syringe user to have the dexterityof an accepted, larger diameter barrel syringe (such as, for thepreparation and administration of medication) as well as bettervisibility, particularly for smaller volume injections, and visibilityof the corresponding indicia.

The syringe may be volumetrically calibrated and its indicia adjustedfor the dosage strength of the particular medication that is appropriatefor a patient in a specific weight range, m², or dosage range. Thisallows clearer and more gradient-correlated dosage-to-weight or BSA (m²)calibrated indicia for precise dosages than standard non-calibratedindustry syringes (See FIG. 9). This feature permits volumes to becalibrated and measured in a smaller, more precise, gradient indiciascale for lower incremental doses, such as dosages for infants,pediatric patients, and other patients who are unusually sensitive tothe medication as well as for the injection of extremely potent anddangerous medications such as pain management, anesthetics, biologicsand oncology drugs than standard non-calibrated industry syringes (SeeFIG. 10).

The syringe may also offer a fluorescent (or other colored) rubberpiston gasket at the plunger tip, whereby maximum visual accuracy isobtained in preparing and verifying the dosage per calibration scale.(See FIG. 4, feature 404).

Further embodiments of the present invention allow the user to see thedosage of the subject medication in a singular calibrated measurementindicia that specifically correlates to another calibrated measurementindicia corresponding to the patient's weight or othercharacteristic(s), etc. (See FIGS. 1-3).

Further embodiments of the present invention also offer a calibratedmeasurement indicia for a manufacturer's maximum suggested dosage of asubject medication that also specifically correlates to anothercalibrated measurement indicia corresponding to the patient's weight orother characteristic(s). (See FIGS. 1-3).

In further embodiments, the syringes of the present invention may alsobear additional separate pre-calculated measurement indicia specificallydesigned for a subject medication that enables the user to verify thathe or she is administering the correct dosage. (See FIGS. 1-3).

The present invention substantially eliminates risk of human errorassociated with computations ordinarily conducted by healthcareprofessionals relative to performing dosage-to-patient weight or BSAcalculations, provided the user follows the pre-calibrated indicia onthe syringe. This, in turn, eliminates the primary cause of MedicalAdministered Errors (MAE) for injected medications.

The pre-packaged combinatorial kit of the present disclosure containinga reconstitutable medication, the corresponding diluent(s), and thepre-calibrated syringe(s) for the medication and diluent(s) within thekit, substantially eliminates multiple methods and procedures that arethe leading direct cause of MAE from an injectable administration. Thecombination kit substantially completely eliminates vital userprocedures and methods ordinarily conducted by healthcare professionals,specifically: the collection of the correct medication for patient andpatient class, the correct corresponding diluent(s) for particularmedication, the correct diluent(s), syringe and needle for theparticular route of administration, the correct calculation, measurementand procedures for the correct reconstitution of the medication by thediluent(s), the calculation determination of dosage-to-patient weight orBSA, and the subsequent verification of these procedures prior to theinjection. The removal of these procedures and methods substantiallyeliminates the risk of human error associated with them. This, in turn,substantially eliminates the primary causes of Medical AdministeredErrors (“MAE”) for injected medications. (See FIG. 7).

The pre-packaged combinatorial kit of the present disclosure containinga medication in solution form, and the pre-calibrated correlatingsyringe(s) for the medication within the kit, substantially eliminatesmultiple methods and procedures that are the leading direct cause of MAEfrom an injectable administration. The combination kit substantiallycompletely eliminates vital user procedures and methods ordinarilyconducted by healthcare professionals, specifically: the collection ofthe correct medication for patient class, the syringe and needle for theparticular route of administration, and the calculation determination ofdosage-to-patient weight or BSA, and the subsequent verification ofthese procedures prior to the injection. The removal of these proceduresand methods substantially eliminates the risk of human error associatedwith them. This, in turn, substantially eliminates the primary cause ofMedical Administered Errors (“MAE”) for injected medications. (See FIG.7)

In a further embodiment of the present disclosure, the pre-packagedcombinatorial kit containing a reconstitutable medication, thecorresponding diluent(s) for the reconstitution(s), and thepre-calibrated syringe for the medication within the kit may yet furthereliminate additional industry standard procedural user steps and methodsincluding: research, calculations, measurements and verifications forthe correct volume of diluent(s) necessary for the correctreconstitution(s) of the medication within the vial. The diluent(s)within the kit is volumetrically specifically calibrated to offer thecorrect dilution of the medication within the kit. The user needs onlyto withdraw the diluent completely from the vial or ampoule and then tocompletely inject that volume into the vial of the medication, thuseliminates multiple methods and procedures that are direct causes of MAEfrom an injectable administration.

In a further embodiment of the present disclosure, the pre-packagedcombinatorial kit containing a reconstitutable medication may also havea calibrated syringe for the diluents(s) within the kit that wouldprovide specific indicia to provide the proper withdrawal of the diluentinto the diluent syringe for the subsequent correct procedures andmethods for the reconstitution of the medication within the kit.

In a further embodiment of the present disclosure, the pre-packagedcombinatorial kit may contain one of more syringes or needles for thesyringes. Embodiments of the present disclosure substantially reduce thecost associated with having healthcare providers prepare, collect, andcorrelate the correct components for the medicinal injection for aparticular patient because the present invention eliminates the need fora healthcare provider to perform these functions and the need for thecalculation to then be verified, and the administration authorized, by asupervisor or other healthcare provider.

Variations of the present disclosure may substantially reduce a heathcare institution's liability insurance costs by reducing and/oreliminating MAE that result from the injection of medications and alsoby implementing a more sophisticated passive safety system, and methodsand apparatus than typical industry standard practices.

According to embodiments of the present disclosure, the incorporatedmeasurement indicia on the syringe offers crucial double or triplevisual re-confirmations, including, for example, dosage to patientweight or BSA, name of medication, recommended dosage to weight and/ormaximum dosage per weight, allowing the user to perform last-minutesafety checks, and thereby discontinue or revise the dosage whilepreparing or even administering the medication. These enhanced visualaids further prevent incorrect or over-dosage of the patient even at thelast stages of the administration. (See FIGS. 1-6).

According to further embodiments of the present disclosure, the internalcore diameter of the syringe barrel may be reduced to enable holdingsmaller volumes of the medication in a thinner barrel (a barrel having areduced diameter), thereby making the measurement indicia more precise.A smaller core diameter makes it possible for the medication to befurther disbursed in the syringe barrel, thus effectively extending thevolume of the medication further into the syringe barrel. The calibratedvolume in the barrel enables the dosage-to-patient-weight-calibratedmeasurement indicia to be visually enhanced by expanding the measurementindicia into a larger elongated scale and thus also offering moreprecise and lower graduated measurement increments. This visualenhancement will also help ensure the administration accuracy forsmaller, more precise doses, such as, for example, doses for pediatricpatients, etc. (See FIGS. 9 and 10).

In still further embodiments of the present disclosure, the internalcore diameter of the syringe barrel may be adjusted by through variousdesign features, yet the exterior diameter of the syringe barrel may notbe adjusted, enabling the user to have the dexterity and/or bettervisibility of a larger diameter barrel syringe for the preparation andadministration. (See FIGS. 8 and 9.)

Another embodiment of the disclosure is directed to a vial or ampoule orother container containing a pre-determined volumetric measurement of aspecific medication that would specifically correlate to thedosage-to-weight or dosage-to-BSA calibrated measurement indicia on thesyringe. This pre-determined amount could then be loaded into thesyringe at the time the medication is administered to the patient.Accordingly, in this embodiment, there would be no calculations orcorrelations necessary for the user to load the syringe from the vial orampoule or other container to the correct dosage of the medication tothe patient's weight for administration.

Additional embodiments contemplate allowing the dosage to patient weightcalibrated measurement indicia on the syringe to uniquely targetspecific weight scales, customized for adult, pediatric, or infantweight, etc. The calibrated measurement indicia scale would therebyallow better visibility as it is specifically focused on a particularweight and patient range allowing for more accurate incremental dosagesand less over all waste through this volume-scaled patient rangecalibration. (See FIG. 6).

Embodiments of the present disclosure consist of a single-use syringethat is pre-filled at the time of manufacture with a pre-determinedvolume of a particular medication. The specific dosage of the subjectmedication could then be administered according to the syringe'scalibrated measurement indicia that is pre-calculated based on theweight of the patient or BSA and the correlating dosage. It furtherallows the user to see the dosage of the subject medication in onecalibrated measurement indicia that specifically correlates to anothercalibrated measurement indicia corresponding to the patient's weight orBSA.

In another variation, the syringe may come in a combination kitcontaining a separate pre-filled (either dry or liquid) vial or ampouleinjectable medication that is specifically volume-scaled to solelycorrelate with the syringe's volumetric design and calibratedmeasurement indicia. (See FIG. 6). In this case, the syringe could beloaded and administered without the need for any calculations of thesubject medication to patient weight. The syringe would also be a“ready-to-fill” syringe that would have various preselected indiciastamped on it including, for example, the name of medication, strengthof medication and the dosage strength-to-patient weight, etc. (See FIGS.4-7).

In another embodiment, the syringe may come in a combination kitcontaining a separate pre-filled dry vial injectable medication with acorresponding vial or ampoule of diluent for reconstitution of the dryvial injectable medication into a solution. Both the dry powder vial ofthe injectable medication and the corresponding diluent are alsospecifically volume-scaled to solely correlate each other with thesyringe's volumetric design and calibrated measurement indicia. In thisembodiment, the diluent would be completely extracted by the syringefrom the diluent vial or ampoule, thereby eliminating the need formeasurement or calculation and then completely injected into the drypowder vial of the injectable medication for the reconstitution of thepowder into a solution. The injectable medication then is extracted outof the vial with the syringe according to the proper weight indicia onthe syringe, and then medication is administered to the patient. All ofthese steps substantially eliminate the need for calculations orcorrelations of the medication's reconstitution and the calculation ofthe subject medication to patient weight based upon the uniquepre-calibration and correlation of the invention itself. (See FIG. 7).

In another embodiment, the syringe plunger in both versions, pre-filledand ready to fill, may be substantially permanently stamped with one ormore identifying designations including, for example, name of themedication that it contains, the strength of the medication that itcontains, and the dosage-to-weight correlation for the patient for whomit is intended, etc., thereby helping to prevent the administration ofthe wrong medication and/or wrong dosage strength of the medication tothe patient. Known syringes do not bear this information. (See FIGS.4-5).

There are no known syringes that combine all of these safety aspectsthat enable the user to verify that he or she is using the appropriatesyringe for the patient in question. The present invention's calibratedmeasurement indicia that appear on the syringe barrel are individuallycorrelated to the specific medication and the manufacturer's recommendeddosage amount for the patient's specific weight. The presentdisclosure's syringe indicia therefore addresses and prevents two of themost common MAE's plaguing the health care industry, namely: 1) wrongdosage, and 2) wrong medication.

In addition, embodiments of the present disclosure eliminate the needfor a user to calculate the dosage strength of medication (mcg, cc, iu,mg, ml) to corresponding patient weight or BSA (G, KG, LB, m²). There-verification safety check calibration indicia that appear on thesyringe provide users with several key visual aids to avoid, forexample, administration errors in the dosage of the medication, themedication itself and the strength of the medication, etc. (See FIG. 5).

In one embodiment, the syringe plunger comprises a clear and conspicuoussubstantially permanent indication of at least the medication name,dosage strength and recommended dosage to weight of the medication thatit contains. (See FIGS. 4 and 5). The preferred syringe's safetyre-verification indicators within the calibration measurement indiciaoffer a clear indication of dosage in a column dedicated to MCG, CC, IU,MG, ML, and then substantially simultaneously further offers a clearconversion of the correlating figure in a G, KG, LB, utilizing therecommended manufacturer's dosage schedule in another parallel column(See FIGS. 1-3).

Presently known syringes and kits for administering injectablemedication offer few or no safety checks. In strong contrast, theembodiments of the present invention substantially minimize the risk ofhuman error in the administration of injectable medication to a greaterdegree than any other design presently known. The user does not have tocalculate the appropriate dosage for the individual patient weight toload the syringe from a vial or ampoule or administer the medication.The user must simply follow the syringe's indicia and load and inject,or in the case of a pre-filled syringe, inject the medication accordingto the designed patient weight indicia.

Unlike all known medication administration systems, embodiments of thepresent disclosure may be used for all drug applications, dry fill vial,lyophilized vial, liquid vial, ampoule, and prefilled injection, withouta variation in any way from the original manufacturer-indicatedadministration of the injectable medication or the manufacturer'soriginal regulatory stability approved packaging.

Unlike known medication administration systems, embodiments of thepresent disclosure substantially eliminate the need for complicatedcolor coding, additional containers, calibration, conversion, additionalequipment, drug components, further calculations, open or reusable drugproducts, cleaning and sterilization of any equipment or components,etc. This is because the alternatives of the present disclosure bearindicia that are pre-calibrated to the specific medication for which itis intended. The user is therefore not required to perform any furthercalibrations or calculations.

Further, unlike known products and methods, the present variations willnot require that users undergo any complicated education and/ortraining. Embodiments of the present disclosure offers healthprofessionals, multiple, clear and available visual verificationfeatures and re-verification features to prevent MAE's that othersyringes and devices currently on the market lack.

According to present embodiments, a syringe, in both pre-filled andready-to-fill versions, will be permanently stamped with the name of themedication, dosage strength of medication and recommended dose-to-weighton the plunger, thereby helping to prevent the administration of thewrong medication and/or wrong dosage strength of the medication to thepatient. Known syringes do not bear this information.

According to further embodiments of the present invention, a syringe inboth pre-filled and ready versions will permanently bear the dosagestrength of the medication contained therein on the plunger. See FIG. 4.This will further prevent users from administering the wrong dosage ofthe medication. Known syringes do not bear this conspicuous informationon the plunger.

Further embodiments of the present disclosure contemplate a system, kitand syringe with its calibrated measurement indicia and volumetricdesign comprising a pre-determined, pre-filled volume of the medicinepre-calculated and specifically correlated from the volume strength(MCG, MG, ML, IU, CC) to the patient weight or BSA (G, KG, LB, m²) basedon the particular manufacturer's suggested drug product dosage schedule.The user does not need to perform any calculations to determine theproper dosage. The user must merely know the weight or BSA of thepatient and then use the syringe designed for a patient of such weightrange. All calculations and correlations of volume (MCG, MG, ML, IU, CC,m²) are pre-converted and appear in a corresponding column for theparticular injection into measures of the weight or BSA of the patient(G, KG, LB, m²), corresponding with that particular manufacturer'sinjectable drug product dosage schedule. (See FIGS. 1-3).

Pharmaceutical manufacturers may produce the syringes, according toembodiments of the present disclosure, that are intended for a specifictargeted patient group by volumetric adjusting the syringe's volumecapacity and the calibrated measurement indicia to a targeted patientweight group. In the case of pediatric or infant injectables, a majorissue stems from a typical volume syringe with a large calibration scalefor adults. In most cases, it is much more difficult to accuratelyprepare smaller doses than if the volume and the syringe was downsizedand thus the scale specifically pre-adjusted to that particular patientweight scale (0.5 KG to 10.0 KG in MCG or MG, etc.). (See FIGS. 6-10).

Preferably, the barrel of the syringe may offer two or three or morecalibrated measurement indicia. In one column the medication containedtherein will be measured by volume dosage (MCG, MG, CC, ML, IUstrength). In the second column, for example, a direct correlation tocorresponding patient weight or BSA (G, KG, LB or m²) based upon themanufacturers recommended dosage. The barrel of the syringe may offer athird calibrated measurement indicia column providing yet anothercorrelation in grams, kilograms, pounds or m² that would indicate themaximum dosage schedule for that patient weight or BSA. Preferably,either or all three columns in the calibration scale on the syringecould be clear or color tinted (for example, yellow for recommended doseand red for maximum dose, etc.). (See FIGS. 1-3).

Still further, according to an embodiment of the present disclosure, thesyringe may be pre-filled ready for injection or within a pre-determinedkit containing volumetrically pre-calibrated vials or ampoules whichwould require no calculations or correlations for the subject medicationdosage amount verses weight of patient. This substantially eliminatesthe risk of human error inherent in known systems, methods andapparatuses. The downsizing of a single dose vial or ampoule to anindividual kit for pediatric, creates a cost savings by avoiding thetremendous waste associated with discarding the unused remainder of avial or ampoule of medication that occurs when known syringes are usedfor reduced dosages. The re-use of single use vials is a major healthcontamination problem in the health care industry worldwide today. Thedownsizing of a single dose vial or ampoule to an individual kit forpediatric or other reduced volume dosage reduces the possibility ofre-use of a single use vial based upon the end user not wanting tothrough away such an excess volume of the product. The reduced dosagealso could limit the severity of an over dosage based upon the reducedmedication volumes. (See FIGS. 6-7).

The combination kit of the embodiments of the present disclosurepreferably comprise a calibrated vial or ampoule of medication with apre-calibrated syringe with corresponding calibrated diluent(s), (ifapplicable, antiseptic wipes) and is preferably packaged as a singleunit in a tamper resistant package and may also comprise aninstructional pamphlet for the particular administration of medication,thus consolidating all the necessary components for the injection in onecombination kit. No known syringe or means for administering injectablemedication offers the level of safety and simplicity that the presentinvention provides. (See FIG. 7).

Embodiments of the present disclosure would not need additionalcomponents, combinations of components, equipment, precautionarymethods, product education, instruction, sterilization, cleaning,replacement parts, nor additional stability or regulatory approvals, asare required for known devices deemed to aid and prevent MAE. Further,the present disclosure would not need a complex color coding which wouldrequire education of staff, complex procedures, additional humancalculation, combinatory methods, etc. that would increase thelikelihood of human error and, in the end, result in increased MAE.

Embodiments of the present disclosure would not rely on a safetyplatform based upon a printed sticker or a hand-written sticker or othermark or calibration that would be placed on the syringe or otherapparatus to supply the necessary data for name, strength and dosage orother necessary information for the drug to be administered correctly.These features are necessary under presently known regimens. Placementof a sticker, mark calculation, or other mechanism or device indicatingthis data relies on human calculation and combinatory methods, as wellthe accuracy of the medical professional placing the data sticker on thesyringe and the correct syringe. Regardless of the accuracy of thesticker and it being correctly applied; (to the correct syringe, withthe correct name, with the correct dosage, for the correct patient) theplacement of a sticker or other type of placard still does prevent anMAE based on one of the most common MAE; an overdose or under dose ofthe drug due to improper calculation or misreading the calibration scaleof the syringe when it is being administered by a health careprofessional.

Some known devices seek to create a system under which multiple drugscould be injected through a single syringe with a standard, “one fitsall” calibration in multiple weights, height, age, etc. The non-drugspecific syringe with these pre-determined calibrations is then placedin multi-drug containment systems that will “store” the drug productsuntil syringe distribution. These containment systems would allow thesyringe to withdraw the drug product to the pre-calibrated measurementson the syringe for the syringe then to be readied for injection. Thiscreates a substantial risk of human error. It also requires that themedication be opened and drawn into the syringe, then injected out ofits regulatory manufacturers' approved packaging only to be re-loadedand then injected into the patient, adding multiple human (relied upon)steps, and actually increasing the likelihood of a MAE. Furthermore, theknown administration systems often deviate from the manufacturer'srecommended administration of the drug, and industry regulationsregarding removing pharmaceutical product, especially a pyrogen freeinjectable, out of its regulated intended packaging. Indeed, suchinjectables should not be held in any other packaging other than themanufacturer's original packaging. Only the manufacturer's packaging hasundergone stability studies specifically for those finished dosageformulations and received medical device approvals for the distributionof the individual medicines it deems to handle. Certainly this poses atremendous regulatory and financial burden to incorporate each and everydrug product through such a process, while not solving the underlyingproblems posed by the increased likelihood of MAE. Many vials andampoules are filled with nitrogen blanketing. Once open, they should notbe stored and must be injected. The majority of vials are powdered andthen are reconstituted to a solution for injection as a single dose andare made for immediate injection.

Many injectable medications, including oncology medications, are highlytoxic or cytotoxic. It is crucial that they be exposed only in acontrolled environment. If they are removed from their approvedpackaging, exposed to open air, and aerosolized, they can be extremelyhazardous to the healthcare providers who are handling them.

In addition, any additional containers or containment systems would needto be tested for endo-toxin levels to ensure sterility or be disposed ofafter each use prior to being refilled. Clearly, known syringes withcontainment devices do not eliminate risk of MAEs by because they do notreduce the potential for human error. Instead, they increase thelikelihood of MAE by increasing the need for multiple hands-on methods,procedures, steps and storage.

Furthermore the methods and practices associated with both prior artswould require changes to: health regulations worldwide, manufacturer'sbest mode standards for methods of administration, as well requiresubstantial user education for these non-practiced industry proceduresand activities for the medicinal administration under these scenarios.

Examples of Cost Efficiency of Present Invention Safety Convenience Kit,Vial and/or Ampoule

Embodiments of the present invention allow for the scaled volumeindividualization of vials and ampoules that can are used with thepresent invention. In known practices, a typical single use vial may bein a 500 Mg vial, or a 100 Mg Ampoule (See FIG. 6, feature 601). Furtherto that example, a specific pediatric dosage for that drug is 5 mg/Kg.This would result in a typical pediatric patient weighing less than 40kg (approximately 88 pounds) to require a dosage (according torecommended dosage schedule) of less than 200 mg. As a result, over halfof the vial will be discarded and wasted, (this at the maximum patientbody weight of 40 kg; all weights under 40 kg would only increase thewaste). (See FIGS. 6 and 6A).

This is the common practice when it comes to small dosage requirements,because in the current market there are virtually no products that arespecifically downsized for pediatric dosages. According to embodimentsof the present disclosure, one is able to downsize the vial or ampoule(and syringe by reducing the barrel diameter) to a specific volume size,thereby enabling a specific dosage range for the intended patientapplication. Using the variations and alternatives in the presentdisclosure, one could design a convenience product wherein the drugcould be scaled to an individually targeted weight class For example, apediatric dosage can be scaled for 0.5 kg to 8.0 kg (FIG. 6A, feature606). In this example, over 460 mgs of a 500 mg vial and 60 mg of a 100mg vial would be wasted with current injection technology. There wouldbe no waste using the present invention. The syringe calibration indiciaof the present invention could also be enlarged to effectively offerbetter visibility and more precise incremental indicia, (for example inMCG). This is made possible by the volumetric pre-designed aspects ofthe present invention and product downsizing correlating to the presentdisclosure.

Examples of Cost Efficiency of Present Invention

Embodiments of the present disclosure also allow for the scaled volumeindividualization of pre-filled syringes. In ordinary practices, aleading typical single use pre-filled syringe (PFS) for a popularanesthetic is, for example, in a 50 mg PFS which would be used for theinitial (loading) dosage at a rate of 0.5-1 mg/Kg. Therefore a 50 mg,prefilled syringe would offer enough product suitable or a dosage for apatient of up to 50 kg (110 lb) or to 100 kg (220 lb). This is theminimum size available.

According to embodiments of the present invention, one could design aproduct where the drug could be volumetrically scaled to an individuallytargeted weight class. For example, a pediatric device could be scaledfor 1 kg to 20 kg in a 20 mg embodiment of the present invention. Inthis example, over half of the PFS would not be wasted, and, in theevent of an overdose, the reduced scaled volume of the drug could alsodecrease the size of the overdose and, as a result, the severity of theMAE and adverse event. In this example, the syringe calibration indiciaalso could be enlarged to effectively offer better visibility and moreprecise indicia, (for example in MCG), by the volumetric pre-designedaspects of the syringe and product downsizing for the syringe.

Many modifications, variations, and other embodiments of the presentinvention will come to the mind of one skilled in the field to whichthis invention pertains, having the benefit of the teachings presentedin the foregoing descriptions. Therefore, it is to be understood thatthe invention is not to be limited to the specific embodiments disclosedand that modifications are intended to be included within the scope ofthe appended claims. Although specific terms are employed herein, theyare used in a generic and descriptive sense only and not for purposes oflimitation.

What is claimed is:
 1. A syringe calibrated for use with a singlepredetermined medication, comprising: a barrel having an internalreservoir volumetrically calibrated to contain the single predeterminedmedication; a plunger received within the barrel and axially movablerelative thereto; a first set of graduated indicia marked on the barrelindicating a first predetermined patient characteristic expressed in aunit selected from the group consisting of kg, max kg, lb, max lb, m²,and max m² calibrated to a manufacturers recommended dosage schedule forthe single predetermined medication; a second set of graduated indiciamarked on the barrel indicating a second predetermined patientcharacteristic, different from the first predetermined patientcharacteristic, and expressed in a unit selected from the groupconsisting of kg, max kg, lb, max lb, m², and max m² calibrated to themanufacturers recommended dosage schedule for the single predeterminedmedication; and graduation lines marked on the barrel indicating one ormore of the first set of graduated indicia and the second set ofgraduated indicia.
 2. The syringe of claim 1, further comprising adosage schedule of the single predetermined medication marked on one ormore of the barrel and the plunger.
 3. The syringe of claim 1, whereinat least one of the barrel and the plunger are marked with a name of thesingle predetermined medication.
 4. The syringe of claim 1, wherein thesyringe is empty and ready to be filled.
 5. The syringe of claim 1,wherein the graduation lines correlate the first set of graduatedindicia with the second set of graduated indicia.
 6. The syringe ofclaim 1, wherein the first set of graduated indicia is positioned on thebarrel apart and independent from the second set of graduated indicia,and wherein each of the first and second sets of graduated indiciainclude graduation lines.
 7. The syringe of claim 1, further comprisingdiluent volumetric indicia marked on the barrel indicating diluentvolume for reconstituting the single predetermined medication.
 8. Thesyringe of claim 1, further comprising a third set of graduated indiciamarked on the barrel indicating volumetric dosage of the singlepredetermined medication expressed in a unit selected from the groupconsisting of cc, mg, mcg, IU and ml calibrated to the manufacturersrecommended volumetric dosage for the single predetermined medication.9. A kit, comprising: a medication container containing a volume of asingle predetermined medication; and a syringe volumetrically calibratedfor use with the single predetermined medication, the syringecomprising: (i) a barrel having an internal reservoir volumetricallycalibrated to contain the single predetermined medication; (ii) aplunger received within the barrel and axially movable relative thereto;(iii) a first set of graduated indicia marked on the barrel indicating afirst predetermined patient characteristic expressed in a unit selectedfrom the group consisting of kg, max kg, lb, max lb, m², and max m²calibrated to a manufacturers recommended dosage schedule for the singlepredetermined medication; (iv) a second set of graduated indicia markedon the barrel indicating a second predetermined patient characteristic,different from the first predetermined patient characteristic, andexpressed in a unit selected from the group consisting of kg, max kg,lb, max lb, m², and max m² calibrated to the manufacturers recommendeddosage schedule for the single predetermined medication; and (v)graduation lines marked on the barrel indicating one or more of thefirst set of graduated indicia and the second set of graduated indicia.10. The kit of claim 9, wherein at least one of the barrel and theplunger are marked with the name and manufacturers recommendedvolumetric dosage of the single predetermined medication.
 11. The kit ofclaim 9, wherein the predetermined medication container is a vial or anampoule.
 12. The kit of claim 9, further comprising a diluent containercontaining a volume of diluent compatible for use in reconstituting thesingle predetermined medication according to a predetermined route ofadministration.
 13. The kit of claim 12, wherein the diluent containeris one or more of a vial, ampoule and diluent syringe.
 14. The kit ofclaim 9, wherein the syringe is empty and ready to fill.
 15. The kit ofclaim 9, wherein the syringe further comprises diluent volumetricindicia marked on the barrel indicating diluent volume forreconstituting the single predetermined medication.
 16. The kit of claim9, further comprising instructions in the kit for reconstituting andadministering the single predetermined medication.
 17. The kit of claim9, wherein the graduation lines correlate the first set of graduatedindicia with the second set of graduated indicia.
 18. The kit of claim9, wherein the first set of graduated indicia is positioned on thebarrel apart and independent from the second set of graduated indicia,and wherein each of the first and second sets of graduated indiciainclude graduation lines.
 19. The kit of claim 9, further comprising athird set of graduated indicia marked on the barrel indicatingvolumetric dosage of the single predetermined medication expressed in aunit selected from the group consisting of cc, mg, mcg, IU and mlcalibrated to the manufacturers recommended volumetric dosage for thesingle predetermined medication.